Versius Surgical System Console affected by cybersecurity vulnerability
CMR Surgical Limited is recalling the Versius Surgeon Console (Model V-SS-1020, Software Version Pratchett 1 version 62.1) due to Secure Boot not being enabled at manufacturing, presenting a potential cybersecurity risk.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or actual cybersecurity breaches documented in the source. The hazard is theoretical—a potential vulnerability—and the device is a surgical system used in controlled hospital environments. Moderate severity applies for a Class II precautionary recall with no realized harm.
Plain-English summary
CMR Surgical Limited is recalling the Versius Surgical System US, specifically the Versius Surgeon Console (Model V-SS-1020, Software Version Pratchett 1 version 62.1), distributed nationwide in California. The device is a modular, open console, software-controlled electromechanical system designed for surgeons to perform minimally invasive surgery.
The recall was initiated because Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. The affected units have serial numbers 66495 and 66496, and carry UDI-DI 05060548211226. No expiry date applies to this device.
Facilities using the affected Versius Surgeon Console units should contact CMR Surgical Limited for further guidance on remediation steps.
The recalled product
- Product
- Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system
- Manufacturer
- CMR SURGICAL LIMITED
- Hazard
- cybersecurity-vulnerability
- software-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI 05060548211226 Model No V-SS-1020 Serial Numbers 66495
- 66496 Software Revision Version 62.1 There is no expiry date for this device.
Distribution
Distributed nationwide across the United States.
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